ID

24333

Beschrijving

ONLY TO BE COMPLETED IF THE PATIENT IS WITHDRAWN Part 1 of EW1/ FU1: Early Withdrawal and Follow-up 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Trefwoorden

Versies (1)
  1. 30-07-17 30-07-17 -
Houder van rechten

glaxoSmithKline

Geüploaded op

30 juli 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1

Engels

GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1

1 Formulieren  
Study medication record since last visit
Beschrijving

Study medication record since last visit

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
Study medication record since last visit
Beschrijving

Please complete the study medication record in the Study Medication and Compliance Section at the back of this module.

Datatype

text

Alias
UMLS CUI [1,1]
C2734539
UMLS CUI [1,2]
C0008972
RLS Rating scale
Beschrijving

RLS Rating scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
RLS Rating scale
Beschrijving

Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book

Datatype

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Vital signs
Beschrijving

Vital signs

Alias
UMLS CUI-1
C0518766
Weight in kg
Beschrijving

weight in kg

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439209
Weight in lbs
Beschrijving

Weight in lbs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439219
Weight (without shoes)
Beschrijving

Weight

Datatype

float

Alias
UMLS CUI [1]
C0005910
Pulse
Beschrijving

after 5min sitting

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting systolic blood pressure
Beschrijving

after 5 minutes sitting

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting diastolic blood pressure
Beschrijving

after 5 minutes sitting

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Medical procedures
Beschrijving

Medical procedures

Alias
UMLS CUI-1
C0199171
Medical Procedures
Beschrijving

Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this module

Datatype

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Beschrijving

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant Medication
Beschrijving

Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this module

Datatype

text

Alias
UMLS CUI [1]
C2347852
Adverse reaction
Beschrijving

Adverse reaction

Alias
UMLS CUI-1
C0559546
Adverse reaction
Beschrijving

Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience section at the back of this module

Datatype

text

Alias
UMLS CUI [1]
C0559546
Patient rated scale
Beschrijving

Patient rated scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C1578483
RLS Quality of Live Questionnaire
Beschrijving

If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire

Datatype

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C0035258
SF36 Health Status Survey
Beschrijving

If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire

Datatype

text

Alias
UMLS CUI [1]
C3640521
Medical Outcome Study Sleep Scale
Beschrijving

If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire

Datatype

text

Alias
UMLS CUI [1,1]
C0349674
UMLS CUI [1,2]
C0037313
Work Productivity and Activity Impairment Questionnaire
Beschrijving

If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire

Datatype

text

Alias
UMLS CUI [1]
C3639722
Healthcare resource utilisation - visits/contacts with physician
Beschrijving

Healthcare resource utilisation - visits/contacts with physician

Alias
UMLS CUI-1
C0031831
UMLS CUI-2
C0545082
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
Beschrijving

DO NOT INCLUDE ANY WHILE IN HOSPITAL. If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0545082
Healthcare resource utilisation - visits/contacts with physician
Beschrijving

Healthcare resource utilisation - visits/contacts with physician

Alias
UMLS CUI-1
C0031831
UMLS CUI-2
C0545082
Date of Visit
Beschrijving

date of visit physician

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0031831
Type of physician
Beschrijving

Type of physician

Datatype

integer

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C0332307
Visit location
Beschrijving

Visit location

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0450429
Was the Visit RLS Related?
Beschrijving

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).

Datatype

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Were any tests or procedures prescribed or conducted at this visit?
Beschrijving

tests or procedures during visit

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0039593
UMLS CUI [2,1]
C0545082
UMLS CUI [2,2]
C3274430
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Beschrijving

Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners

Alias
UMLS CUI-1
C0030450
UMLS CUI-2
C0545082
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
Beschrijving

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit:

Datatype

text

Alias
UMLS CUI [1,1]
C0030450
UMLS CUI [1,2]
C0545082
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
Beschrijving

Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners

Alias
UMLS CUI-1
C0030450
UMLS CUI-2
C0545082
Date of visit
Beschrijving

date of visit paramedical practitioner

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0030450
Type of paramedical practitioner
Beschrijving

Type of paramedical practitioner

Datatype

integer

Alias
UMLS CUI [1]
C0030450
Visit location
Beschrijving

Visit location

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0450429
Was the visit RLS related?
Beschrijving

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc).

Datatype

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Healthcare resource utilisation - Hospitalisation
Beschrijving

Healthcare resource utilisation - Hospitalisation

Alias
UMLS CUI-1
C0019993
In the past 4 weeks...was the patient hospitalised?
Beschrijving

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each hospitalisation:

Datatype

integer

Alias
UMLS CUI [1]
C0019993
Healthcare resource utilisation - hospitalisation
Beschrijving

Healthcare resource utilisation - hospitalisation

Alias
UMLS CUI-1
C0019993
Date of admission
Beschrijving

date of admission

Datatype

date

Alias
UMLS CUI [1]
C1302393
Date of discharge
Beschrijving

date of discharge

Datatype

date

Alias
UMLS CUI [1]
C2361123
Main reason for stay
Beschrijving

Hospitalisation cause

Datatype

text

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0392360
Was the Visit RLS Related?
Beschrijving

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.

Datatype

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Type of ward
Beschrijving

type of ward

Datatype

integer

Alias
UMLS CUI [1,1]
C1305702
UMLS CUI [1,2]
C0332307
Length of stay on ward
Beschrijving

in days

Datatype

durationDatetime

Maateenheden
  • days
Alias
UMLS CUI [1,1]
C1305702
UMLS CUI [1,2]
C0023303
days
Healthcare resource utilisation - accident & emergency / emergency room visits
Beschrijving

Healthcare resource utilisation - accident & emergency / emergency room visits

Alias
UMLS CUI-1
C0562508
UMLS CUI-2
C0545082
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
Beschrijving

If ’No’, please leave the rest of this page blank If ’Yes’, please describe each visit

Datatype

integer

Alias
UMLS CUI [1,1]
C0562508
UMLS CUI [1,2]
C0545082
Healthcare resource utilisation - accident & emergency / emergency room visits
Beschrijving

Healthcare resource utilisation - accident & emergency / emergency room visits

Alias
UMLS CUI-1
C0562508
UMLS CUI-2
C0545082
Date of visit
Beschrijving

Date of visit in A&E

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C0562508
Was the visit RLS related?
Beschrijving

A Directly Related RLS visit is one that in your opinion is specifically related to the patient's RLS (e.g. visits for RLS treatment, testing etc). An Indirectly Related RLS visit is one that in your opinion is related to conditions or complications caused by the underlying RLS condition (e.g. visit to treat associated sleep disorders, etc). A Not Related RLS visit is one that in your opinion is related to other reasons.

Datatype

text

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C0439849
Laboratory evaluation
Beschrijving

Laboratory evaluation

Alias
UMLS CUI-1
C0022885
Date of blood sample
Beschrijving

Please take a blood sample for routine analysis.

Datatype

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Beschrijving

Laboratory label

Datatype

text

Alias
UMLS CUI [1]
C4273937
Were any clinically significant abnormalities detected?
Beschrijving

If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this module, send a sample to Quest Diagnostics for further evaluation.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1704258
Urine dipstick
Beschrijving

Urine dipstick

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Beschrijving

Please perform a urine dipstick test for presence of blood or protein. If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this module, send a sample to Quest Diagnostics for further evaluation.

Datatype

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Pregnancy dipstick
Beschrijving

Pregnancy dipstick

Alias
UMLS CUI-1
C0430056
Is the patient a female of child-bearing potential?
Beschrijving

If ’Yes’, please perform a pregnancy dipstick test and record result below.

Datatype

boolean

Alias
UMLS CUI [1]
C1960468
Dipstick Pregnancy Test Result
Beschrijving

Only answer if the patient is a female of child bearing potential. If ’Positive’, please record details on the Pregnancy Notification Form

Datatype

integer

Alias
UMLS CUI [1]
C0427777
Clinical global impression
Beschrijving

Clinical global impression

Alias
UMLS CUI-1
C3639708
Clinical global impression
Beschrijving

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Datatype

text

Alias
UMLS CUI [1]
C3639708
Pregnancy information
Beschrijving

Pregnancy information

Alias
UMLS CUI-1
C0032961
Has the patient become pregnant to date?
Beschrijving

If ’Yes’ please record details on the Pregnancy Notification Form, if not already completed and withdraw the patient.

Datatype

text

Alias
UMLS CUI [1]
C0032961
Study conclusion
Beschrijving

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Did the patient complete the study according to the protocol?
Beschrijving

If 'No' please mark the primary cause of withdrawal.

Datatype

boolean

Alias
UMLS CUI [1]
C2348577
Reason for not completing the study
Beschrijving

Reason for not completing the study

Datatype

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
Please specify other reason for not completing the study.
Beschrijving

Only answer, if you chose 'other' reason for not completing the study.

Datatype

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Investigator signature
Beschrijving

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator signature
Beschrijving

I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Adverse Experience and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date of Investigator signature
Beschrijving

Investigator signature date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Early Withdrawal 1

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Study medication record since last visit
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study medication record since last visit
Item
Study medication record since last visit
text
C2734539 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Item Group
RLS Rating scale
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS Rating scale
Item
RLS Rating scale
text
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
weight in kg
Item
Weight in kg
boolean
C0005910 (UMLS CUI [1,1])
C0439209 (UMLS CUI [1,2])
Weight in lbs
Item
Weight in lbs
boolean
C0005910 (UMLS CUI [1,1])
C0439219 (UMLS CUI [1,2])
Weight
Item
Weight (without shoes)
float
C0005910 (UMLS CUI [1])
Pulse rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting systolic blood pressure
Item
Sitting systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting diastolic blood pressure
Item
Sitting diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Medical procedures
C0199171 (UMLS CUI-1)
Medical Procedures
Item
Medical Procedures
text
C0199171 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Concomitant Medication
text
C2347852 (UMLS CUI [1])
Item Group
Adverse reaction
C0559546 (UMLS CUI-1)
Adverse reaction
Item
Adverse reaction
text
C0559546 (UMLS CUI [1])
Item Group
Patient rated scale
C0681889 (UMLS CUI-1)
C1578483 (UMLS CUI-2)
RLS Quality of Live Questionnaire
Item
RLS Quality of Live Questionnaire
text
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
SF36 Health Status Survey
Item
SF36 Health Status Survey
text
C3640521 (UMLS CUI [1])
Medical Outcome Study Sleep Scale
Item
Medical Outcome Study Sleep Scale
text
C0349674 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
Work Productivity and Activity Impairment Questionnaire
Item
Work Productivity and Activity Impairment Questionnaire
text
C3639722 (UMLS CUI [1])
Item Group
Healthcare resource utilisation - visits/contacts with physician
C0031831 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
visit physician in the last 4 weeks
Item
In the past 4 weeks...did the patient visit your site (for reasons other than study visit) or other medical practitioners?
boolean
C0031831 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Item Group
Healthcare resource utilisation - visits/contacts with physician
C0031831 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
date of visit physician
Item
Date of Visit
date
C1320303 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Item
Type of physician
integer
C0031831 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of physician
Code List
Type of physician
CL Item
Cardiologist (1)
CL Item
Diabetologist (2)
CL Item
Dermatologist (3)
CL Item
Endocrinologist (4)
CL Item
ENT (Ear Nose & Throat) (5)
CL Item
Gastroenterologist (6)
CL Item
General/Internal Medical (7)
CL Item
General Practitioner/Family Practitioner  (8)
CL Item
Geriatrician (9)
CL Item
Gynaecologist (10)
CL Item
Infectious Disease (11)
CL Item
Nephrologist (12)
CL Item
Neurologist (13)
CL Item
Psychiatrist (14)
CL Item
Orthopaedic (15)
CL Item
Oncologist (16)
CL Item
Ophthalmologist (17)
CL Item
Respiratory/Chest Physician  (18)
CL Item
Rheumatologist (19)
CL Item
Urologist (20)
CL Item
Sleep Disorder Specialist  (21)
CL Item
Other (99)
Item
Visit location
integer
C0545082 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Visit location
Code List
Visit location
CL Item
Non hospital Office visit (eg GP surgery, Specialist's office etc) (1)
CL Item
Hospital Out Patient visit (2)
CL Item
At the Patient's home / domiciliary visit (3)
Item
Was the Visit RLS Related?
integer
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the Visit RLS Related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item
Were any tests or procedures prescribed or conducted at this visit?
text
C0545082 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0545082 (UMLS CUI [2,1])
C3274430 (UMLS CUI [2,2])
tests or procedures during visit
Code List
Were any tests or procedures prescribed or conducted at this visit?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item Group
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
C0030450 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Item
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
text
C0030450 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Paramedical Practitioner
Code List
In the past 4 weeks...did the patient visit any or have contact with paramedical practitioners (for reasons other than study visit)?
CL Item
no (1)
CL Item
yes (2)
Item Group
Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners
C0030450 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
date of visit paramedical practitioner
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C0030450 (UMLS CUI [1,2])
Item
Type of paramedical practitioner
integer
C0030450 (UMLS CUI [1])
Type of paramedical practitioner
Code List
Type of paramedical practitioner
CL Item
Acupuncturist (1)
CL Item
Chiropodist/ Footcare Practitioner (2)
CL Item
Chiropractor (3)
CL Item
Dentist (4)
CL Item
Dietician (5)
CL Item
Homeopath/Herbalist (6)
CL Item
Nurse (7)
CL Item
Osteopath (8)
CL Item
Physiotherapist (9)
CL Item
Other (99)
Item
Visit location
integer
C0545082 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Visit location
Code List
Visit location
CL Item
Non hospital Office visit (1)
CL Item
Hospital Out Patient visit (2)
CL Item
At the Patient's home / domiciliary visit (3)
Item
Was the visit RLS related?
integer
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the visit RLS related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item Group
Healthcare resource utilisation - Hospitalisation
C0019993 (UMLS CUI-1)
Item
In the past 4 weeks...was the patient hospitalised?
integer
C0019993 (UMLS CUI [1])
Hospitalisation
Code List
In the past 4 weeks...was the patient hospitalised?
CL Item
no (1)
CL Item
yes (2)
Item Group
Healthcare resource utilisation - hospitalisation
C0019993 (UMLS CUI-1)
date of admission
Item
Date of admission
date
C1302393 (UMLS CUI [1])
date of discharge
Item
Date of discharge
date
C2361123 (UMLS CUI [1])
Hospitalisation cause
Item
Main reason for stay
text
C0019993 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item
Was the Visit RLS Related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the Visit RLS Related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item
Type of ward
integer
C1305702 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
type of ward
Code List
Type of ward
CL Item
Cardiovascular (1)
CL Item
Dermatological (2)
CL Item
Endocrinological (3)
CL Item
ENT (Ear, Nose & Throat)  (4)
CL Item
Gastroenterological (5)
CL Item
General Medical (6)
CL Item
Geriatric (7)
CL Item
Gynaecological (8)
CL Item
Infectious Disease  (9)
CL Item
Nephrological (10)
CL Item
Intensive Care  (11)
CL Item
Neurological  (12)
CL Item
Psychiatric (13)
CL Item
Orthopaedic  (14)
CL Item
Oncology (15)
CL Item
Ophthalmological  (16)
CL Item
Respiratory/Chest  (17)
CL Item
Rheumatological  (18)
CL Item
Urological (19)
CL Item
Other (99)
length of stay on ward
Item
Length of stay on ward
durationDatetime
C1305702 (UMLS CUI [1,1])
C0023303 (UMLS CUI [1,2])
Item Group
Healthcare resource utilisation - accident & emergency / emergency room visits
C0562508 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Item
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
integer
C0562508 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
A&E visits
Code List
In the past 4 weeks...did the patient visit an Accident and Emergency or EMERGENCY ROOM?
CL Item
no (1)
CL Item
yes (2)
Item Group
Healthcare resource utilisation - accident & emergency / emergency room visits
C0562508 (UMLS CUI-1)
C0545082 (UMLS CUI-2)
Date of visit in A&E
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C0562508 (UMLS CUI [1,2])
Item
Was the visit RLS related?
text
C0035258 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Related to RLS
Code List
Was the visit RLS related?
CL Item
directly (1)
CL Item
indirectly (2)
CL Item
not related (3)
Item Group
Laboratory evaluation
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C4273937 (UMLS CUI [1])
laboratory results abnormalities
Item
Were any clinically significant abnormalities detected?
boolean
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Urine dipstick
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
urine dipstick result
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
negative (1)
CL Item
positive (2)
Item Group
Pregnancy dipstick
C0430056 (UMLS CUI-1)
female of child-bearing potential
Item
Is the patient a female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
Item
Dipstick Pregnancy Test Result
integer
C0427777 (UMLS CUI [1])
Pregnancy Test Result
Code List
Dipstick Pregnancy Test Result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Clinical global impression
C3639708 (UMLS CUI-1)
Clinical global impression
Item
Clinical global impression
text
C3639708 (UMLS CUI [1])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
Item
Has the patient become pregnant to date?
text
C0032961 (UMLS CUI [1])
pregnancy
Code List
Has the patient become pregnant to date?
CL Item
Not applicable (not of childbearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
study completed
Item
Did the patient complete the study according to the protocol?
boolean
C2348577 (UMLS CUI [1])
Item
Reason for not completing the study
integer
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason
Code List
Reason for not completing the study
CL Item
Adverse experience (please complete AE page) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other-specify (7)
Specify other reason
Item
Please specify other reason for not completing the study.
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Date of Investigator signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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